FDA WARNING_LETTER - Carib Supply of St. Croix, Inc. - June 27, 2008

This FDA Warning Letter, SJN-09-04, dated November 20, 2008, addresses Carib Supply of St. Croix, Inc. following an inspection on June 26-27, 2008, and a follow-up on October 6, 2008, at their Christiansted, St. Croix facility. The inspection revealed deviations from Current Good Manufacturing Practice (CGMP) Regulations (21 CFR Parts 210 and 211) in the manufacture of medical grade oxygen, rendering the drug product adulterated under 21 U.S.C. § 351(a)(2)(B).

Key violations include: 1. **Failure to establish a quality control unit (21 CFR § 211.22(a), (d)):** No designated unit, written procedures, or documentation of batch record review. Corrective actions were incomplete, lacking promised documentation. 2. **Failure to test each batch for identity and strength (21 CFR § 211.165(a)):** No identity/strength testing on bulk or finished oxygen since January 2008, and odor tests were not performed. Promised documentation of new test procedure implementation was missing. 3. **Failure to establish and follow scientifically sound specifications and test procedures (21 CFR § 211.16